2. Introduction
Requirements of this International Standard are applicable to organizations regardless of their
size and regardless of their type except where explicitly stated
The processes required by this International Standard that are applicable to the organization,
but are not performed by the organization.
The responsibility of the organization and are accounted for in the organization’s quality
management system by monitoring, maintaining, and controlling the processes.
3. Clause 4 Quality management system
General requirements
The organization shall establish, implement and maintain any requirement, procedure, activity or
arrangement required to be documentent.
The organization shall:
Determine the processes needed for the quality management system and the application of these
processed by this International Standard
Apply a risk based approach to the control of the appropriate processes needed for the quality
management system
Determine the sequence and interaction of these processes
4. Determine criteria and methods needed to ensure that both the operation and control of these
processes are effective
Ensure the availability of resources and information necessary to support the operation
Implement actions necessary to achieve planned results
establish and maintain records needed to demonstrate conformance to ISO
5. Documentation requirements
Documented statements of a quality policy and quality objectives
A quality manual;
Documented procedures and records required by this International Standard;
Documents, including records, determined by the organization to be necessary to ensure the
effective planning, operation, and control of its processes;
6. Quality manual
The organization shall document a quality manual that includes
a) The scope of the quality management system, including details of and justification for any
exclusion or non-application;
b) The documented procedures for the quality management system, or reference to them;
c) A description of the interaction between the processes of the quality management system.
7. Medical device file
The content of the file(s) shall include,
General description of the medical device (intended use, and labelling, including any IFU)
Specifications for product;
Specifications or procedures for manufacturing, packaging, storage, handling and distribution;
Procedures for measuring and monitoring;
Requirements for installation;
As appropriate, procedures for servicing
8. Control of documents
A documented procedure shall define the controls needed to:
Review and approve documents for adequacy prior to issue;
Review, update as necessary and re-approve documents;
Ensure that the current revision status of and changes to documents are identified;
Ensure that relevant versions of applicable documents are available at points of use;
9. Conti…
Ensure that documents remain legible and readily identifiable;
Ensure that documents of external origin, determined by the organization to be necessary for
the planning and operation of the quality management system, are identified and their
distribution controlled;
Prevent deterioration or loss of documents;
Prevent the unintended use of obsolete documents and apply suitable identification to them
10. Control of records
Records shall be maintained to provide evidence of conformity to requirements
The organization shall
-Define and implement methods for protecting confidential health information contained in
records
-Records shall remain legible, readily identifiable and retrievable
-Retain the records for at least the lifetime of the medical device as defined by the organization, or
as specified by applicable regulatory requirements, but not less than two years from the medical
device release by the organization.
11. Clause 5 Management Responsibility
Responsibility and authority
Top management shall:-
Ensure that responsibilities and authorities are defined, documented and communicated within the
organization
Document the interrelation of all personnel who manage, perform and verify work affecting quality.
12. Management representative
Top management shall appoint a member of management who, has responsibility and authority that
includes:-
Ensuring that processes needed for the quality management system are documented
Reporting to top management on the effectiveness of the quality management system and any
need for improvement.
Ensuring the promotion of awareness of applicable regulatory requirements and quality
management system requirements throughout the organization
Internal communication -Top management shall ensure that appropriate communication processes
are established within the organization
13. Management review
Top management shall review the organization’s quality management system at documented
planned intervals to ensure its continuing suitability, adequacy and effectiveness.
Review shall include assessing opportunities for improvement and the need for changes to the
quality management system
14. Review input
a) Feedback; b) complaint handling;
c) reporting to regulatory authorities; d) audits;
e) monitoring and measurement of processes; f) monitoring and measurement of product;
g) corrective action; h) preventive action;
15. Review Output
Improvement needed to maintain the suitability, adequacy, and effectiveness
Improvement of product related to customer requirements;
c) changes needed to respond to applicable new or revised regulatory requirements;
d) resource needs.
16. Clause 6 Resource management
The organization shall determine and provide the resources needed to:
a) Implement the quality management system and to maintain its effectiveness;
b) Meet applicable regulatory and customer requirements
17. Human resources
Personnel performing work affecting product quality shall be competent
The organization shall:
a) determine the necessary competence for personnel performing work affecting product
quality;
b) provide training or take other actions to achieve or maintain the necessary competence;
c) evaluate the effectiveness of the actions taken;
d) ensure that its personnel are aware of the relevance and importance of their activities
18. Infrastructure
The organization shall document the requirements for the infrastructure needed to achieve
conformity to product requirements
a) buildings, workspace and associated utilities;
b) process equipment (both hardware and software);
c) supporting services (such as transport, communication, or information systems)
19. Work environment and contamination
The organization shall document the requirements for the work environment needed to
achieve conformity to product requirement
As appropriate, the organization shall plan and document arrangements for the control of
contaminated or potentially contaminated product in order to prevent contamination of the
work environment
20. Clause 7 Product realization
Planning of Product Realization
Documented processes for risk management
Required planning for verification, validation, monitoring, measurement, inspection, test activities,
handling, storage, distribution, & traceability
Determination of product requirements
Any user training needed to ensure specified performance and safe use of the medical device
Review of product requirements
Applicable regulatory requirements are met
any user training identified and available or planned to be available
Communication
The organization shall communicate with regulatory authorities in accordance with applicable regulatory
requirements
22. Clause 8 Measurement, Analysis and
Improvement
Monitoring and measurement
Feedback procedures, input to risk management and improvement process.
Requires procedures for timely complaint handling, investigation, regulatory notification and more
Procedures for reporting to regulatory authorities regarding complaints are required
Monitoring and measurement of product
Test equipment shall be identified as appropriate
details in respect of controls, concessions, records.
Verifying that CAPA does not have an adverse effect, actions to be taken without undue delay
